US Food and Drug Administration's Advancing Real-World Evidence Program: Initial Experience

Abstract

Advances in the availability and analysis of real-world data (RWD) have enabled the generation of robust real-world evidence (RWE) to support regulatory decision making by the US Food and Drug Administration. Realizing the full potential of RWE in a regulatory environment requires cross-discipline expertise and collaboration to increase confidence in RWE-based approaches. The FDA's Advancing RWE Program was established to address this need by providing a new option for regulatory interactions on RWE-based approaches.